Clinical Programs

The core technology behind Mitotech products is based on a novel class of small molecules – mitochondria addressed cardiolipin peroxidation inhibitors. Mitotech is developing several drug formulations of SkQ1 covering a variety of therapeutic areas and methods of administration. The most advanced SkQ1-based drug product in Mitotech’s pipeline is Visomitin™ which reached Phase III stage in the U.S. for Dry Eye Disease. Visomitin™ already received marketing approval for Dry Eye Disease in Russia. Multifactorial nature of Dry Eye made this indication a perfect target for SkQ1 as its mechanism of action addresses tissue degeneration, oxidative stress of the tear and inflammation at the same time. Clinical studies demonstrated effect of Visomitin™ on corneal staining, tear quality and a range of symptoms of this disease.

Other indications in Mitotech’s pipeline include other ophthalmic (LHON, dry AMD, uveitis and more), neurodegenerative, cardiovascular and metabolic disorders and are at earlier stages of clinical development.

US

Drug/Indication

Pre-clinical

Phase 1

Phase 2

Phase 3

Visomitin™ (SkQ1 eye drops)

Dry Eye

Phase III initiated

Uveitis

Phase II ready

Dry AMD

Phase II ready

Plastomitin™ (SkQ1 pill)

Multiple Sclerosis

Phase I ready

Acute Kidney Injury

Phase I ready

Barth Syndrome

Phase I ready

Russia

Drug/Indication

Pre-clinical

Phase 1

Phase 2

Phase 3

Visomitin™ (SkQ1 eye drops)

Dry Eye

Marketing approval received

LHON

Phase II completed

Dry AMD

Pre-clinical Completed

Plastomitin™ (SkQ1 pill)

Neurodegeneration

Phase II ready

Mitotech is committed to adding therapeutic indications that are important for millions of patients worldwide as well as rare genetic disorders to its development pipeline to make sure SkQ1 technology realizes its full pharmaceutical potential.